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Beskrivning av behandlingsmönster och skapa ett uppdaterat behandlingsflöde i en ulcerös kolitpopulation (EFFECT-1LAT)

5 november 2026 uppdaterad av: Pfizer

Beskrivning av receptbelagda mönster i en ulcerös kolitpopulation och generering av ett uppdaterat ulcerativt kolitbehandlingsparadigm

Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Exploring the long-term outcomes of uncontrolled inflammation, and how does early switching to advanced treatments affect disease outcomes and inflammation control in patients with poorly controlled ulcerative colitis.

Studietyp

Observationell

Inskrivning (Faktisk)

4000

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

19 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

The Lothian IBD registry (LIBDR) was compiled through a capture-recapture methodology, describes the observed prevalence of IBD in Lothian between 2008 and 2018, and has been maintained as a prospective registry since 1 August 2018 and thus the study period is up to 1st August 2025 (2008 - 2025). The study size is expected to be a defined population of approximately 4000 UC patients, with more than 600 having commenced an advanced therapy. The study period will be from 2008 - 2025.

Beskrivning

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

  1. Patient enrolled in IBD registry from 2009
  2. >18 years at time of diagnosis.
  3. Diagnosis of Ulcerative Colitis.
  4. Patient data entered during the study period.
  5. Minimum duration of data post UC diagnosis (Cohort A: 6 months, Cohort B-D 6 months)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiv: RETROSPECTIVE

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Cohort A

Patients within the Lothian IBD registry, approximately 4000 patients, of which 3200 are on conventional therapy.
Läkemedel: Non-Interventional Study

As provided in real world practice

Andra namn:
  • adalimumab
  • tofacitinib
  • infliximab
  • risankizumab
  • vedolizumab
  • golimumab
  • etrasimod
  • ustekinumab
  • ozanimod
  • upadicitinib
  • filgotinib
  • guselkumab
Cohort B

Patients with uncontrolled inflammation defined as two or more episodes of raised CRP or faecal calprotectin recording 6-24 months post UC diagnosis.
Läkemedel: Non-Interventional Study

As provided in real world practice

Andra namn:
  • adalimumab
  • tofacitinib
  • infliximab
  • risankizumab
  • vedolizumab
  • golimumab
  • etrasimod
  • ustekinumab
  • ozanimod
  • upadicitinib
  • filgotinib
  • guselkumab
Cohort C

Patients with steroid dependent controlled inflammation defined as normal CRP and faecal calprotectin but the requirement of a dose of steroids between 6-24 months.
Läkemedel: Non-Interventional Study

As provided in real world practice

Andra namn:
  • adalimumab
  • tofacitinib
  • infliximab
  • risankizumab
  • vedolizumab
  • golimumab
  • etrasimod
  • ustekinumab
  • ozanimod
  • upadicitinib
  • filgotinib
  • guselkumab
Cohort D

Patients with controlled inflammation defined as the absence of steroid requirement or normal CRP or faecal calprotectin 6-24 months post UC diagnosis
Läkemedel: Non-Interventional Study

As provided in real world practice

Andra namn:
  • adalimumab
  • tofacitinib
  • infliximab
  • risankizumab
  • vedolizumab
  • golimumab
  • etrasimod
  • ustekinumab
  • ozanimod
  • upadicitinib
  • filgotinib
  • guselkumab

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Proportion of patients that achieve early control of inflammation on conventional therapeutics within 6-24 months of UC diagnosis.
Tidsram: 6-24 months from UC diagnosis.

Proportion of patients that achieve early control of inflammation on conventional therapeutics within 6-24 months of UC diagnosis in the Lothian inflammatory bowel disease registry (LIBDR).
6-24 months from UC diagnosis.
Difference in proportion of patients with inadequate control of inflammation (defined as two or more episodes of raised CRP or faecal calprotectin) treated with conventional therapeutics versus treatment escalation 24 months post UC diagnosis.
Tidsram: 24 months

Explore the differences in long term outcomes for patients with uncontrolled inflammation, treated with prolonged conventional therapeutics versus treatment escalation up to 24 months for patients with inadequate control of inflammation in the Lothian inflammatory bowel disease registry (LIBDR).
24 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Characterise patient demography at the time of diagnosis and associated co-morbidities and extra-intestinal manifestations of interest.
Tidsram: Baseline demography.

Characterise patient demography at the time of UC diagnosis and associated co-morbidities and extra-intestinal manifestations of interest in the Lothian inflammatory bowel disease registry (LIBDR).
Baseline demography.
Map treatment use from conventional therapies to advanced therapies from time of UC diagnosis.
Tidsram: Study period is up to 1st August 2025 (2008 - 2025).

Map treatment use from from conventional therapies to advanced therapies from time of UC diagnosis in the Lothian inflammatory bowel disease registry (LIBDR).
Study period is up to 1st August 2025 (2008 - 2025).
Change from Baseline in Faecal Calprotectin (Fcal).
Tidsram: Study period is up to 1st August 2025 (2008 - 2025).

Generate Faecal Calprotectin (Fcal) profile and longitudinal inflammatory response models for patients on conventional therapy in the Lothian inflammatory bowel disease registry (LIBDR).
Study period is up to 1st August 2025 (2008 - 2025).
Change from Baseline in C-Reactive Protein (CRP).
Tidsram: Study period is up to 1st August 2025 (2008 - 2025).

Generate C-Reactive Protein (CRP) profile and longitudinal inflammatory response models for patients on conventional therapy in the Lothian inflammatory bowel disease registry (LIBDR).
Study period is up to 1st August 2025 (2008 - 2025).
Proportion of patients with colectomies from baseline.
Tidsram: Study period is up to 1st August 2025 (2008 - 2025).

Assess colectomy rates of patients in the Lothian inflammatory bowel disease registry (LIBDR) with a relevant UC diagnosis.
Study period is up to 1st August 2025 (2008 - 2025).
Proportion of patients with hospitalisations from baseline.
Tidsram: Study period is up to 1st August 2025 (2008 - 2025).

Assess hospitalisation rates in the Lothian inflammatory bowel disease registry (LIBDR) with a relevant UC diagnosis.
Study period is up to 1st August 2025 (2008 - 2025).
Proportion of patients with advanced therapy (AT) requirements with relevant UC diagnosis.
Tidsram: Study period is up to 1st August 2025 (2008 - 2025).

Assess advanced therapy (AT) requirements in the Lothian inflammatory bowel disease registry (LIBDR).
Study period is up to 1st August 2025 (2008 - 2025).
Correlate duration of uncontrolled inflammation within first 6-24 months of treatment to long term outcomes as provided in real world evidence practice.
Tidsram: Study period is up to 1st August 2025 (2008 - 2025).

Duration of uncontrolled inflammation in the Lothian inflammatory bowel disease registry (LIBDR).
Study period is up to 1st August 2025 (2008 - 2025).
Describe the effects of conventional treatment to AT's (etrasimod and tofacitinib) by change from baseline in steroid utilisation.
Tidsram: Study period is up to 1st August 2025 (2008 - 2025).

Effects of conventional treatment to advanced therapies (AT's) in steroid utilisation in the Lothian inflammatory bowel disease registry (LIBDR).
Study period is up to 1st August 2025 (2008 - 2025).
Change from baseline in control of inflammation (CRP or faecal calprotectin) in patients that are moved from conventional treatments to advanced treatments with a UC diagnosis.
Tidsram: From baseline, study period is up to 1st August 2025 (2008 - 2025).

Describe the effects of changing from conventional treatment to advanced treatments (etrasimod and tofacitinib) in control of inflammation (CRP or faecal calprotectin) in the Lothian inflammatory bowel disease registry (LIBDR).
From baseline, study period is up to 1st August 2025 (2008 - 2025).

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Pfizer

Utredare

  • Studierektor: Pfizer CT.gov Call Center, Pfizer

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 april 2026

Primärt slutförande (Faktisk)

30 oktober 2026

Avslutad studie (Faktisk)

30 oktober 2026

Studieregistreringsdatum

Först inskickad

1 augusti 2025

Först inskickad som uppfyllde QC-kriterierna

9 september 2025

Första postat (Faktisk)

16 september 2025

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • C5041058

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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